HC Restores Curtailed Oxygen Supply Of State, Pulls Up FDA For Lax ...

HC restores curtailed oxygen supply of State, pulls up FDA for lax enforcement 22 Apr 2021 09:44:01 Staff Reporter : Summons Drug Controller of India to explain steps taken to control supply of Remdesivir across States In a historic hearing in three sessions, including a late night hearing that lasted till 10.30 pm, Nagpur bench of Bombay High Court directed restoration of curtailed oxygen supply from 60 metric tonne to earlier 110 metric tonne. Pulling up Food and Drug Administration (FDA) authorities and pharmaceutical companies for not rising to the occasion to help the suffering patients, the High Court directed FDA to conduct raids against hoarders, black-marketeers and supply at least 100 Remdesivir vials to Government Medical College and Hospital (GMCH) by night. When the High Court was informed that combined manufacturing capacity of all seven major pharmaceutical companies was 88 lakh Remdesivir vials per month, it observed that this was presently sufficient to meet the demand and sought more details from the Central agency. Directing the Drug Controller of India to remain personally present on Friday at 2.30 pm, the High Court directed him to explain steps taken by the regulator under Drugs Control Act to ensure equitable and fair distribution of Remdesivir in Maharashtra and other States. A division bench consisting of Justice Sunil Shukre and Justice Shriram Modak, during the hearing of a suo-motu PIL, initially pulled up the State authorities and blasted them for total inaction and for shirking the responsibility to procure and supply Remdesivir and Oxygen. The first virtual hearing witnessed a very strong reaction from the bench, which asked the State and officials whether they felt ashamed or not. The second hearing was then convened in the High Court auditorium in which the officials were under fire for quite some time for passing the buck to manufacturers and restricting their role. Rejecting this, the High Court directed immediate meeting of Nagpur COVID-19 committee and also distributors, C&F agents and stockists of life-saving drugs, and initiate stern action against black-marketeers. Within two hours, the authorities led by Dr Sanjeev Kumar, Divisional Commissioner; Ravindra Thakare, District Collector; and Radhakrishnan B, Municipal Commissioner, swung into action and obtained concrete assurance from the seven drug manufacturing companies about supply of 6,752 additional vials of Remdesivir by Wednesday night or latest by Thursday evening. Dr Kumar informed that in compliance to April 19 order directing supply of 10,000 Remdesivir vials, already 5,245 vials were supplied. Turning the heat on Central Drug Controller, the High Court directed his presence -- virtual or physical -- along with all information about various steps taken under law to control supply of Remdesivir across States and Maharashtra and action taken to stop hoarding and black-marketing. The High Court pointed out that the Drug Controller had massive powers under Drug Control Act and several other statutes to direct pharmaceutical companies to increase production, ensure proper supply and also to take stringent action in case of non-supply or deliberate under-supply. The High Court asked the Drug Controller to explain in detail steps taken to ensure fair and equitable supply of life-saving drugs. About dismal Oxygen supply scenario, the High Court expressed its disappointment. All top officials listed several measures taken by them to get more supply, but their helplessness and limitations were evident to everybody present in the High Court auditorium. Total requirement of Nagpur is 166.5 metric tonne and that of other districts of Vidarbha is around 100 tonne. There is shortfall of around 100 metric tonne due to curtailment of supply from Bhilai. Nagpur has Oxygen generating units with 146 tonne capacity. However, the Ministry of Health and Family Welfare, vide a communication dated April 18, reduced the Oxygen quota of Maharashtra from 110 metric tonne to 60 metric tonne which created acute shortage of about 100 metric tonne. It was also pointed out that there was no fixed quota for State but consistent practice of supplying liquid oxygen of 110 metric tonne was followed. The High Court, while directing Bhilai supplier Prax Air to restore the quota and continue the supply of 110 metric tonne, noted that Maharashtra accounted for 40 per cent of COVID-19 patients and the Ministry of Health and Family Welfare instead of increasing the quota had reduced it, thereby adversely affecting Vidarbha region. Adv Shreerang Bhandarkar (Amicus Curiae), Adv Sudhir Puranik (NMC), ASGI Ulhas Aurangabadkar (Union), Senior Advocate M G Bhangde, In-charge GP Ketaki Joshi and Additional GP Deepak Thakre (State), Adv Bhanudas Kulkarni (IMA), Adv Tushar Mandlekar and Adv Rohan Malviya (intervener), and Adv M Anil Kumar (Intervenor) appeared in the matter. GMCH gets 100 Remdesivir vials in 1 hr After the High Court pulling up the authorities, GMCH got 100 Remdesivir vials within one hour. The High Court had entrusted the task to Vijay Kose, FDA Joint Commissioner, to ensure delivery of 100 vials to GMCH where close to 900 patients were admitted with almost nil stock of this life-saving drug. The High Court had directed Dr Sudhir Gupta, GMCH Dean, to inform Sunil Bharuka, Registrar of the High Court, about compliance of this order after receipt of 100 vials. The warning had its desired impact and the GMCH Dean got the vials by 11.35 pm from Neeta Agencies. The High Court Registrar confirmed this development. ‘Our hearts bleed for hapless patients’ “Our hearts bleed for the hapless patients. All of us are spending sleepless nights. With folded hands we request officials to join this fight against deadly virus.” These moving words by Justice Shukre at the end of a marathon hearing moved everybody present in the High Court auditorium. Dr Sanjeev Kumar, Divisional Commissioner; Ravindra Thakare, District Collector; and Radhakrishnan B, Municipal Commissioner; also responded equally graciously and spontaneously assuring the High Court to do their best to help the patients and healthcare system in this collective fight against COVID-19 pandemic. While the hearing witnessed several sharp remarks from the bench, the judges made it very clear that they were not after credit or trying to blame anyone. “Ultimately, we will have to find way to provide some succour to patients and citizens eagerly waiting for some positive news from this hearing,” the High Court noted. Medical fraternity represented by Dr Anil Laddhad, Dr Anup Marar expressed their deep gratitude towards the High Court while describing the hearing as “historic and unprecedented.” Powered By Sangraha 9.0